Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group

NCT ID: NCT05754593

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2026-12-31

Brief Summary

The investigators want to evaluate ovarian reserve concerning patients with multiple sclerosis, compared to a control group of healthy women. This study will include women from 25 to 35 years old.

Detailed Description

Multiple sclerosis is an inflammatory disease of central nervous system, with a prevalence rate in France of 1 case/1000 subjects. The average age at diagnosis is 30 years old and it affects especially women, with a sex ratio of 3 women for 1 men. Multiples sclerosis concerns women at a moment when fertility is a main issue.

Few studies suggest that there is an negative impact of multiple sclerosis on ovarian reserve, with a combined mechanism ( inflammatory and autoimmune mechanism). The investigators can hypothesize that patients with multiple sclerosis are more predisposed to have primary ovarian insufficiency.

Ovarian reserve is evaluated by Anti-Mullerian Hormone (AMH) dosage and antral follicle count (AFC) by ultrasound imaging.AMH levels can be measured at every moment of the menstrual cycle whereas AFC is preferentially performed between the second and the eighth day of the menstrual cycle. The combined use of this two markers is well known to be correlated with ovarian reserve. Only a few studies have evaluated ovarian reserve in patients with multiple sclerosis. Besides, there is only a few number of participants and results are contradictory. A decrease of ovarian reserve identified among patients with multiple sclerosis could lead to an orientation in a fertility preservation center.

This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center. Healthy women come from a volunteer base contacted by email.The two groups are matched thanks to answers of a short questionnaire.Measure of AMH level is performed at pellegrin Hospital at the medical laboratory. Ultrasound imaging is performed by the center of women imagery at Pellegrin Hospital. Results are communicated by teleconsultation two months later. If there is an anormal result, a specific appointment will be organized with a gynecologist.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MS patients

Diagnosis of multiple sclerosis based on McDonald Criteria 2017

Group Type: EXPERIMENTAL

Anti-Mullerian hormone (AMH) level

Intervention Type: BIOLOGICAL

Measure of Anti-Mullerian hormone (AMH) level by blood sample

Antral follicle count (AFC)

Intervention Type: OTHER

Measure of Antral follicle count (AFC) by ultrasound imaging

Clinical assessment

Intervention Type: OTHER

MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded

Controls

Healthy controls

Group Type: ACTIVE_COMPARATOR

Anti-Mullerian hormone (AMH) level

Intervention Type: BIOLOGICAL

Measure of Anti-Mullerian hormone (AMH) level by blood sample

Antral follicle count (AFC)

Intervention Type: OTHER

Measure of Antral follicle count (AFC) by ultrasound imaging

Interventions

Anti-Mullerian hormone (AMH) level

Measure of Anti-Mullerian hormone (AMH) level by blood sample

Intervention Type: BIOLOGICAL

Antral follicle count (AFC)

Measure of Antral follicle count (AFC) by ultrasound imaging

Intervention Type: OTHER

Clinical assessment

MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Reproductive women between 25 and 35 years old ;
• MS Patient : Diagnosis of multiple sclerosis based on McDonald Criteria 2017;
• French-speaking, without comprehension disorders ;
• being affiliated to health insurance ;
• Willing to participate and to sign informed consent.

Exclusion Criteria

• History of ovarian surgery (cystectomy, annexectomy) ;
• Turner Syndrome ;
• fragile X messenger ribonucleoprotein 1 (FMR1) premutation ;
• Endometriosis with a risk of ovarian reserve alteration ;
• History of chemotherapy or pelvic radiotherapy ;
• Pregnant or breastfeeding women ;
• patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valérie BERNARD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Antoine BERNARD, MD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CHU de Bordeaux - service de neurologie

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Valérie BERNARD, MD

Role: CONTACT

valerie.bernard@chu-bordeaux.fr

(0)5 56 79 56 79 ext. +33

Mathilde DELOIRE, PhD

Role: CONTACT

mathilde.deloire@chu-bordeaux.fr

(0)5.57.82.12.75 ext. +33

Facility Contacts

Valérie BERNARD, MD

Role: primary

valerie.bernard@chu-bordeaux.fr

(0)5 56 79 56 79 ext. +33

Mathilde DELOIRE, PhD

Role: backup

mathilde.deloire@chu-bordeaux.fr

(0)5.57.82.12.75 ext. +33

Other Identifiers

CHUBX 2022/27

Identifier Type: -

Identifier Source: org_study_id